A Phase 1, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Doses of Vanzacaftor/Tezacaftor/Deutivacaftor on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- VNZ/TEZ/D-IVA
- Conditions
- Not specified
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Maximum Observed Concentration (Cmax) of Rosuvastatin in the Absence and Presence of VNZ/TEZ/D-IVA
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with rosuvastatin.
Detailed Description
The study is being conducted to evaluate the effect of multiple doses of VNZ/TEZ/D-IVA on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with rosuvastatin in healthy participants. Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR11.60and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24and11.44.).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
- •A total body weight greater than (\>)50 kg
Exclusion Criteria
- •History of febrile illness within 5 days before the first dose of study drug
- •Any condition possibly affecting drug absorption
- •Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
- •Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
VNZ/TEZ/D-IVA and Rosuvastatin
Rosuvastatin will be administered to participants as a single oral dose on Day 1 and then co-administered with VNZ/TEZ/D-IVA on Day 18.VNZ/TEZ/D-IVA dose will be administered once daily (qd) from Day 5 to Day 22.
Intervention: VNZ/TEZ/D-IVA
VNZ/TEZ/D-IVA and Rosuvastatin
Rosuvastatin will be administered to participants as a single oral dose on Day 1 and then co-administered with VNZ/TEZ/D-IVA on Day 18.VNZ/TEZ/D-IVA dose will be administered once daily (qd) from Day 5 to Day 22.
Intervention: Rosuvastatin
Outcomes
Primary Outcomes
Maximum Observed Concentration (Cmax) of Rosuvastatin in the Absence and Presence of VNZ/TEZ/D-IVA
Time Frame: Day 1 up to Day 23
Area Under the Concentration Time-curve (AUC) of Rosuvastatin in the Absence and Presence of VNZ/TEZ/D-IVA
Time Frame: Day 1 up to Day 23
Secondary Outcomes
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to Day 39)